plazomicin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| aminoglycosides, antibiotics obtained from various Micromonospora | 5287 | 1154757-24-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Plazomicin is an aminoglycoside that acts by binding to bacterial 30S ribosomal subunit, thereby inhibiting protein synthesis. Plazomicin has concentration-dependent bactericidal activity as measured by time kill studies. In vitro studies demonstrated a plazomicin post-antibiotic effect ranging from 0.2 to 2.6 hours at 2X MIC against Enterobacteriaceae.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.22 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 1.14 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.84 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 3.40 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 50 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 25, 2018 | FDA | ACHAOGEN INC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J01GB14 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE AMINOGLYCOSIDE ANTIBACTERIALS Other aminoglycosides |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Urinary tract infectious disease | indication | 68566005 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 12.04 | acidic |
| pKa2 | 13.21 | acidic |
| pKa3 | 13.84 | acidic |
| pKa4 | 9.4 | Basic |
| pKa5 | 9.12 | Basic |
| pKa6 | 8.51 | Basic |
| pKa7 | 7.43 | Basic |
| pKa8 | 6.73 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | ZEMDRI | CIPLA USA | N210303 | June 25, 2018 | RX | SOLUTION | INTRAVENOUS | 9266919 | Nov. 21, 2028 | METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS |
| EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | ZEMDRI | CIPLA USA | N210303 | June 25, 2018 | RX | SOLUTION | INTRAVENOUS | 9688711 | Nov. 21, 2028 | METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS |
| EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | ZEMDRI | CIPLA USA | N210303 | June 25, 2018 | RX | SOLUTION | INTRAVENOUS | 8383596 | June 2, 2031 | METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | ZEMDRI | CIPLA USA | N210303 | June 25, 2018 | RX | SOLUTION | INTRAVENOUS | June 25, 2023 | NEW CHEMICAL ENTITY |
| EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | ZEMDRI | CIPLA USA | N210303 | June 25, 2018 | RX | SOLUTION | INTRAVENOUS | June 25, 2028 | GENERATING ANTIBIOTIC INCENTIVES NOW |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| LYO9XZ250J | UNII |
| 1380078-95-4 | SECONDARY_CAS_RN |
| C3502652 | UMLSCUI |
| EDS | PDB_CHEM_ID |
| CHEMBL1650559 | ChEMBL_ID |
| 42613186 | PUBCHEM_CID |
| DB12615 | DRUGBANK_ID |
| CHEMBL2364623 | ChEMBL_ID |
| D10151 | KEGG_DRUG |
| 9522 | INN_ID |
| 10847 | IUPHAR_LIGAND_ID |
| 34453 | MMSL |
| d08816 | MMSL |
| 017613 | NDDF |
| 017619 | NDDF |
| 1193790007 | SNOMEDCT_US |
| 725719004 | SNOMEDCT_US |
| 772052009 | SNOMEDCT_US |
| 4037688 | VANDF |
| 2049549 | RXNORM |
| C550938 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Zemdri (plazomicin) | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69097-820 | INJECTION | 500 mg | INTRAVENOUS | NDA | 30 sections |
| Zemdri (plazomicin) | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69097-820 | INJECTION | 500 mg | INTRAVENOUS | NDA | 30 sections |
| Zemdri (plazomicin) | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71045-010 | INJECTION | 500 mg | INTRAVENOUS | NDA | 29 sections |
| Zemdri (plazomicin) | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80735-820 | INJECTION | 500 mg | INTRAVENOUS | NDA | 30 sections |
| Zemdri (plazomicin) | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80735-820 | INJECTION | 500 mg | INTRAVENOUS | NDA | 30 sections |